FDA.reportPublic FDA data

n.a.

Primary DI
04048551253687
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
404038
Device description
Fiber optic light carrier for 404055H
Published
2017-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FCSLight, catheter, fiberoptic, glass, ureteral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCSLight, Catheter, Fiberoptic, Glass, UreteralGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551253687PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551253687040485512536874048551253687

GMDN Terms#

Term, Definition table
TermDefinition
Fibreoptic light cable, reusableA flexible fibreoptic cable that is designed to transport cold light from a light source to an instrument or other equipment, e.g., an endoscope or a headlight. The fibreoptic bundle is protected within a sheath and can be made of either glass or plastic fibres. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fibreoptic bundle. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Hydrogen Peroxide"", ""Liquid Chemical"", ""Ethylene Oxide""]"

Regulatory Flags#

DUNS number
315731430
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048551001141n.a.495NCS2016-09-23
04048551004401n.a.495TIP2016-09-23
04048551004463n.a.50200FFL2018-08-21
04048551028568n.a.495ADM2016-09-23
04048551049549n.a.10970AE2018-08-17
04048551049563n.a.10970BE2018-08-17
04048551052495n.a.12016EM2016-09-23
04048551052525n.a.12016FM2016-09-23
04048551052990n.a.12061A2016-09-23
04048551053003n.a.12061AU2016-09-23
04048551053010n.a.12061AV2016-09-23
04048551053027n.a.12061AW2016-09-23
04048551053034n.a.12061AX2016-09-23
04048551053041n.a.12061B2016-09-23
04048551053065n.a.12061C2016-09-23
04048551053072n.a.12061F2016-09-23
04048551053089n.a.12061G2016-09-23
04048551053096n.a.12061H2016-09-23
04048551053102n.a.12061K2016-09-23
04048551082027n.a.233250B2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048551169629n.a.Karl Storz GmbH & Co. KGFCS2018-08-24
00827002161436BushCOOK INCORPORATEDFCS2016-09-24
00827002162624BushCOOK INCORPORATEDFCS2016-09-24
00827002167377BushCOOK INCORPORATEDFCS2016-09-24
00827002167452BushCOOK INCORPORATEDFCS2016-09-24
00827002167469BushCOOK INCORPORATEDFCS2016-09-24
00827002167476BushCOOK INCORPORATEDFCS2016-09-24
07613327061215InfraVisionSTRYKER CORPORATIONFCS2016-09-23
07613327174816IRISSTRYKER CORPORATIONFCS2016-09-23
37613327061216InfraVisionSTRYKER CORPORATIONFCS2016-09-23